TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30- brightening skni tint lotion

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Octisalate 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am – 2 pm, wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor

Inactive Ingredients

Aqua/Water/Eau, C9-12 Alkane , Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Triethylhexanoin, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Isododecane, Silica, Butylene Glycol, Disteardimonium Hectorite, Trimethylsiloxysilicate, VP/Eicosene Copolymer, Glycerin, Argania Spinosa Kernel Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer, Octyldodecyl Neopentanoate, Sodium Chloride, Magnesium Sulfate, Boron Nitride, Sorbitan Oleate, Polyglycerin-6, Caesalpinia Spinosa Fruit Extract, Octyldodecanol, Safflower oil/ Palm oil aminopropanediol esters , Mica , Lactococcus Ferment Lysate, Alpha-Glucan Oligosaccharide, Hydrogenated Lecithin, Bisabolol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Simethicone, Kappaphycus Alvarezii Extract, Pongamia Glabra Seed Oil , Beta Vulgaris (Beet) Root Extract, Cystoseira Tamariscifolia Extract, Inulin, Niacinamide, Tocopherol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Lactic Acid, Polymnia Sonchifolia Root Juice, Lactobacillus Ferment, Curcuma Longa (Turmeric) Root Extract, Maltodextrin, Ceramide NP, Dunaliella Salina Extract , Haematococcus Pluvialis Extract , Acacia Seyal Gum Extract, Lactobacillus, Ethylhexylglycerin, Aluminum Hydroxide, Sodium Hyaluronate, Citric Acid, 1,2-Hexanediol, Caprylyl Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

PRINCIPLE DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 
brightening skni tint lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER (UNII: 4VBL71TY4Y)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
BORON NITRIDE (UNII: 2U4T60A6YD)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ACACIA SEYAL WHOLE (UNII: 0H7YR6DN6P)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECANOL (UNII: 461N1O614Y)
TURMERIC (UNII: 856YO1Z64F)
CYSTOSEIRA TAMARISCIFOLIA (UNII: HRU0KH4VFH)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYGLYCERIN-6 (UNII: M51422LRAM)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)
LACTIC ACID (UNII: 33X04XA5AT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARGAN OIL (UNII: 4V59G5UW9X)
BETA VULGARIS (UNII: 4G174V5051)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INULIN (UNII: JOS53KRJ01)
CERAMIDE NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PENTAERYTHRITOL 3,5-DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: A8VXR0397K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
KARUM SEED OIL (UNII: 62160PU6FJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
SORBITAN (UNII: 6O92ICV9RU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	brown (SHADE 23 TAN-DEEP OLIVE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-207-01	1 in 1 CARTON	08/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2022

Labeler - MANA PRODUCTS, INC (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-207)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		078870292	manufacture(59735-207)